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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Alloy, Amalgam
510(k) Number K951663
Device Name TYTIN R
Applicant
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact JEFFREY A ANDERSON
Correspondent
Kerr Corporation (Danbury)
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact JEFFREY A ANDERSON
Regulation Number872.3070
Classification Product Code
EJJ  
Date Received04/10/1995
Decision Date 06/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
Recalls CDRH Recalls
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